July 7th, 2014 by admin in Humor, Quackery Exposed, Research
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Twenty years ago I started my job as ‘Professor of Complementary Medicine’ at the University of Exeter and became a full-time researcher of all matters related to alternative medicine. One issue that was discussed endlessly during these early days was the question whether alternative medicine can be investigated scientifically. There were many vociferous proponents of the view that it was too subtle, too individualised, too special for that and that it defied science in principle. Alternative medicine, they claimed, needed an alternative to science to be validated. I spent my time arguing the opposite, of course, and today there finally seems to be a consensus that alternative medicine can and should be submitted to scientific tests much like any other branch of health care.
Looking back at those debates, I think it is rather obvious why apologists of alternative medicine were so vehement about opposing scientific investigations: they suspected, perhaps even knew, that the results of such research would be mostly negative. Once the anti-scientists saw that they were fighting a lost battle, they changed their tune and adopted science – well sort of: they became pseudo-scientists (‘if you cannot beat them, join them’). Their aim was to prevent disaster, namely the documentation of alternative medicine’s uselessness by scientists. Meanwhile many of these ‘anti-scientists turned pseudo-scientists’ have made rather surprising careers out of their cunning role-change; professorships at respectable universities have mushroomed. Yes, pseudo-scientists have splendid prospects these days in the realm of alternative medicine.
The term ‘pseudo-scientist’ as I understand it describes a person who thinks he/she knows the truth about his/her subject well before he/she has done the actual research. A pseudo-scientist is keen to understand the rules of science in order to corrupt science; he/she aims at using the tools of science not to test his/her assumptions and hypotheses, but to prove that his/her preconceived ideas were correct.
So, how does one become a top pseudo-scientist? During the last 20 years, I have observed some of the careers with interest and think I know how it is done. Here are nine lessons which, if followed rigorously, will lead to success (… oh yes, in case I again have someone thick enough to complain about me misleading my readers: THIS POST IS SLIGHTLY TONGUE IN CHEEK).
- Throw yourself into qualitative research. For instance, focus groups are a safe bet. This type of pseudo-research is not really difficult to do: you assemble about 5 -10 people, let them express their opinions, record them, extract from the diversity of views what you recognise as your own opinion and call it a ‘common theme’, write the whole thing up, and – BINGO! – you have a publication. The beauty of this approach is manifold: 1) you can repeat this exercise ad nauseam until your publication list is of respectable length; there are plenty of alternative medicine journals who will hurry to publish your pseudo-research; 2) you can manipulate your findings at will, for instance, by selecting your sample (if you recruit people outside a health food shop, for instance, and direct your group wisely, you will find everything alternative medicine journals love to print); 3) you will never produce a paper that displeases the likes of Prince Charles (this is more important than you may think: even pseudo-science needs a sponsor [or would that be a pseudo-sponsor?]).
- Conduct surveys. These are very popular and highly respected/publishable projects in alternative medicine – and they are almost as quick and easy as focus groups. Do not get deterred by the fact that thousands of very similar investigations are already available. If, for instance, there already is one describing the alternative medicine usage by leg-amputated police-men in North Devon, and you nevertheless feel the urge of going into this area, you can safely follow your instinct: do a survey of leg-amputated police men in North Devon with a medical history of diabetes. There are no limits, and as long as you conclude that your participants used a lot of alternative medicine, were very satisfied with it, did not experience any adverse effects, thought it was value for money, and would recommend it to their neighbour, you have secured another publication in an alternative medicine journal.
- Take a sociological, anthropological or psychological approach. How about studying, for example, the differences in worldviews, the different belief systems, the different ways of knowing, the different concepts about illness, the different expectations, the unique spiritual dimensions, the amazing views on holism – all in different cultures, settings or countries? Invariably, you will, of course, conclude that one truth is at least as good as the next. This will make you popular with all the post-modernists who use alternative medicine as a playground for getting a few publications out. This approach will allow you to travel extensively and generally have a good time. Your papers might not win you a Nobel prize, but one cannot have everything.
- Do a safety study. It could well be that, at one stage, your boss has a serious talk with you demanding that you start doing what (in his narrow mind) constitutes ‘real science’. He might be keen to get some brownie-points at the next RAE and could thus want you to actually test alternative treatments in terms of their safety and efficacy. Do not despair! Even then, there are plenty of possibilities to remain true to your pseudo-scientific principles. By now you are good at running surveys, and you could, for instance, take up your boss’ suggestion of studying the safety of your favourite alternative medicine with a survey of its users. You simply evaluate their experiences and opinions regarding adverse effects. But be careful, you are on somewhat thinner ice here; you don’t want to upset anyone by generating alarming findings. Make sure your sample is small enough for a false negative result, and that all participants are well-pleased with their alternative medicine. This might be merely a question of selecting your patients cleverly. The main thing is that your conclusion is positive. If you want to go the extra pseudo-scientific mile, mention in the discussion of your paper that your participants all felt that conventional drugs were very harmful.
- Publish case reports. If your boss insists you tackle the daunting issue of therapeutic efficacy, there is no reason to give up pseudo-science either. You can always find patients who happened to have recovered spectacularly well from a life-threatening disease after receiving your favourite form of alternative medicine. Once you have identified such a person, you write up her experience in much detail and call it a ‘case report’. It requires a little skill to brush over the fact that the patient also had lots of conventional treatments, or that her diagnosis was assumed but never properly verified. As a pseudo-scientist, you will have to learn how to discretely make such irritating details vanish so that, in the final paper, they are no longer recognisable. Once you are familiar with this methodology, you can try to find a couple more such cases and publish them as a ‘best case series’ – I can guarantee that you will be all other pseudo-scientists’ hero!
- Publish a case series. Your boss might point out, after you have published half a dozen such articles, that single cases are not really very conclusive. The antidote to this argument is simple: you do a large case series along the same lines. Here you can even show off your excellent statistical skills by calculating the statistical significance of the difference between the severity of the condition before the treatment and the one after it. As long as you show marked improvements, ignore all the many other factors involved in the outcome and conclude that these changes are undeniably the result of the treatment, you will be able to publish your paper without problems.
- Rig the study design. As your boss seems to be obsessed with the RAE and all that, he might one day insist you conduct what he narrow-mindedly calls a ‘proper’ study; in other words, you might be forced to bite the bullet and learn how to plan and run an RCT. As your particular alternative therapy is not really effective, this could lead to serious embarrassment in form of a negative result, something that must be avoided at all cost. I therefore recommend you join for a few months a research group that has a proven track record in doing RCTs of utterly useless treatments without ever failing to conclude that it is highly effective. There are several of those units both in the UK and elsewhere, and their expertise is remarkable. They will teach you how to incorporate all the right design features into your study without there being the slightest risk of generating a negative result. A particularly popular solution is to conduct what they call a ‘pragmatic’ trial, I suggest you focus on this splendid innovation that never fails to produce anything but cheerfully positive findings.
- Play with statistics until you get the desired result. It is hardly possible that this strategy fails – but once every blue moon, all precautions turn out to be in vain, and even the most cunningly designed study of your bogus therapy might deliver a negative result. This is a challenge to any pseudo-scientist, but you can master it, provided you don’t lose your head. In such a rare case I recommend to run as many different statistical tests as you can find; chances are that one of them will nevertheless produce something vaguely positive. If even this method fails (and it hardly ever does), you can always home in on the fact that, in your efficacy study of your bogus treatment, not a single patient died. Who would be able to doubt that this is a positive outcome? Stress it clearly, select it as the main feature of your conclusions, and thus make the more disappointing findings disappear.
- Create confirmatory studies that follow your rigged design and faulty statistics. Now that you are a fully-fledged pseudo-scientist who has produced one misleading or false positive result after the next, you may want a ‘proper’ confirmatory study of your pet-therapy. For this purpose run the same RCT over again, and again, and again. Eventually you want a meta-analysis of all RCTs ever published. As you are the only person who ever conducted studies on the bogus treatment in question, this should be quite easy: you pool the data of all your trials and, bob’s your uncle: a nice little summary of the totality of the data that shows beyond doubt that your therapy works. Now even your narrow-minded boss will be impressed.
These nine lessons can and should be modified to suit your particular situation, of course. Nothing here is written in stone. The one skill any pseudo-scientist must have is flexibility.
Every now and then, some smart arse is bound to attack you and claim that this is not rigorous science, that independent replications are required, that you are biased etc. etc. blah, blah, blah. Do not panic: either you ignore that person completely, or (in case there is a whole gang of nasty skeptics after you) you might just point out that:
- your work follows a new paradigm; the one of your critics is now obsolete,
- your detractors fail to understand the complexity of the subject and their comments merely reveal their ridiculous incompetence,
- your critics are less than impartial, in fact, most are bought by BIG PHARMA,
- you have a paper ‘in press’ that fully deals with all the criticism and explains how inappropriate it really is.
In closing, allow me a final word about publishing. There are hundreds of alternative medicine journals out there to chose from. They will love your papers because they are uncompromising promotional. These journals all have one thing in common: they are run by apologists of alternative medicine who abhor to read anything negative about alternative medicine. Consequently hardly a critical word about alternative medicine will ever appear in these journals. If you want to make double sure that your paper does not get criticised during the peer-review process (this would require a revision, and you don’t need extra work of that nature), you can suggest a friend for peer-reviewing it. In turn, you can offer to him/her that you do the same to him/her the next time he/she has an article to submit. This is how pseudo-scientists make sure that the body of pseudo-evidence for their pseudo-treatments is growing at a steady pace.
***
Dr. Ernst is a PM&R specialist and the author of 48 books and more than 1000 articles in the peer-reviewed medical literature. His most recent book, Trick or Treatment? Alternative Medicine on Trial is available from amazon. He blogs regularly at EdzardErnst.com and contributes occasionally to this blog.
December 17th, 2012 by admin in Quackery Exposed
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Miracles are pretty rare events. Except on television’s “Dr. Oz Show,” where they appear with astonishing frequency. Oz of course doesn’t claim to raise the dead or part the Red Sea, but he does raise people’s hopes of parting with their flab. And he’s certainly not shy about flinging the word “miracle” about. But it seems miracles fade as quickly as they appear. Raspberry ketones, acai berries and African mango, once hyped as amazing “fat busters,” have already given way to newer wonders.
Granted, Dr. Oz, or more likely his producers, do not pull miracles out of an empty hat. They generally manage to toss in a smattering of stunted facts that they then nurture into some pretty tall tales. Like the ones about chlorogenic acid or Garcinia cambogia causing effortless weight loss. The former piqued the public’s interest when the great Oz introduced green coffee bean extract as the next diet sensation. Actually “chlorogenic acid” is not a single compound, but rather a family of closely related compounds found in green plants, which perhaps surprisingly, contain no chlorine atoms. The name derives from the Greek “chloro” for pale green and “genic” means “give rise to.” (The element chlorine is a pale green gas, hence its name.)
An “unprecedented” breakthrough, Dr, Oz curiously announced, apparently having forgotten all about his previous weight-control miracles. This time the “staggering” results originate from a study of green coffee bean extract by Dr. Joe Vinson, a respected chemist at the University of Scranton who has a long-standing interest in antioxidants, such as chlorogenic acid. Aware of the fact that chlorogenic acid had been shown to influence glucose and fat metabolism in mice, Vinson speculated that it might have some effect on humans as well. Since chlorogenic acid content is reduced by roasting, a green bean extracts was chosen for the study.
In cooperation with colleagues in India who had access to volunteers, Dr. Vinson designed a trial whereby overweight subjects were given, in random order, for periods of six weeks each, either a daily dose of 1,050 mg of green coffee bean extract, a lower dosage of 700 mg, or a placebo. Between each six-week phase there was a two-week “washout” period during which the participants took no supplements. There was no dietary intervention; the average daily calorie intake was about 2,400. Participants burned roughly 400 calories a day with exercise. On average there was a loss of about a third of a kilogram per week. Interesting, but hardly “staggering.” And there are caveats galore.
The study involved only eight men and eight women, which amounts to a statistically weak sample. Diet was self-reported, a notoriously unreliable method. The subjects were not really blinded since the high dose regimen involved three pills, the lower dose only two. A perusal of the results also shows some curious features. For example, in the group that took placebo for the first six weeks, there was an 8 kilogram weight loss during the placebo and washout phase, but almost no further loss during the high dose and low dose phases. By the time, though, that critics reacted to Oz’s glowing account, overweight people were already panting their way to the health food store to pick up some green coffee bean extract that might or might not contain the amount of chlorogenic acid declared on the label. As for Dr. Oz, he had already moved on to his next “revolutionary” product, Garcinia cambogia, unabashedly describing it as the “Holy Grail” of weight loss.
We were actually treated to the Grail in action. Sort of. Dr. Oz, with guest Dr. Julie Chen, performed a demonstration using a plastic contraption with a balloon inside that was supposed to represent the liver. A white liquid, supposedly a sugar solution, was poured in, causing the balloon, representing a fat cell, to swell. Then a valve was closed, and as more liquid was introduced, it went into a different chamber, marked “energy.” The message was that the valve represents Garcinia extract, which prevents the buildup of fat in fat cells. While playing with balloons and a plastic liver may make for entertaining television, it makes for pretty skimpy science.
Contrary to Dr. Oz’s introduction that “you are hearing it here first,” there is nothing new about Garcinia. There’s no breakthrough, no fresh research, no “revolutionary” discovery. In the weight control field, Garcinia cambogia is old hat. Extracts of the rind of this small pumpkin-shaped Asian fruit have long been used in “natural weight loss supplements” Why? Because in theory, they could have an effect.
The rind of the fruit, sometimes called a tamarind, is rich in hydroxycitric acid (HCA), a substance with biological activity that can be related to weight loss. Laboratory experiments indicate that HCA can interfere with an enzyme that plays a role in converting excess sugar into fat, as well as with enzymes that break down complex carbohydrates to simple sugars that are readily absorbed. Furthermore, there are suggestions that Garcinia extract stimulates serotonin release which can lead to appetite suppression.
Laboratory results that point toward possible weight loss don’t mean much until they are confirmed by proper human trials. And there have been some. Fifteen years ago a randomized trial involving 135 subjects who took either a placebo or a Garcinia extract equivalent to 1500 mg of HCA a day for three months, showed no difference in weight loss between the groups. A more recent trial involving 86 overweight people taking either two grams of extract or placebo for ten weeks echoed those results. In-between these two major studies there were several others, some of which did show a weight loss of about one kilogram over a couple of months, but these either had few subjects or lacked a control group. Basically, it is clear that if there is any weight loss attributed to Garcinia cambogia, it is virtually insignificant. But there may be something else attributed to the supplement, namely kidney problems. Although incidence is rare, even one is an excess when the chance of a benefit is so small. So Garcinia cambogia, like green coffee bean extract, can hardly be called a miracle. But it seems Dr. Oz puts his facts on a diet when it comes to fattening up his television ratings.
joe.schwarcz@mcgill.ca
Joe Schwarcz is director of McGill University’s Office for Science & Society (mcgill.ca/oss). He hosts The Dr. Joe Show on CJAD Radio 800 AM every Sunday from 3 to 4 p.m.
November 26th, 2012 by admin in Quackery Exposed, True Stories
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What did the jockey who never lost a race whisper into the horse’s ear? “Roses are red, violets are blue, Horses that lose are made into glue!” OK, so it’s a groaner. But until the advent of polyvinyl acetate (PVA) and other synthetic glues in the twentieth century, the destiny of aging horses was indeed the glue factory. The collagen extracted from their hides, connective tissues and hooves made for an ideal wood adhesive. Our word “collagen” for the group of proteins found in these tissues actually derives from the Greek “kolla” for “glue.”
Not all aging horses were dispatched to the glue factory after their plow-pulling days came to an end. Some farmers found they could squeeze a little more profit out of the animals by assigning them another duty. They would become leech collectors! The elderly horses were driven into swampy waters only to emerge coated with the little bloodsucking worms. It seems the creatures found horses to be a particularly tasty treat! Since for many people suffering from various ailments, the little parasites were just what the doctor ordered, the harvesting of leeches made for a lucrative business.
Leeches have actually been used in medicine since they were first introduced around 1500 BC by the Indian sage Sushruta, one of the founders of the Hindu system of traditional medicine known as “Ayurveda.” That translates from the Sanskrit as “knowledge of life.” Sushruta recommended that leeches be used for skin diseases and for various musculoskeletal pains. Ancient Egyptian doctors extended the indications, treating headaches, ear infections and even hemorrhoids in this peculiar fashion. Galen, the famous Roman physician, used leeches to balance the four “humors,” namely blood, phlegm, black bile and yellow bile. Swollen, red skin, for example, was thought to be due to too much blood in the body and the answer was to have leeches slurp the excess.
Curiously, despite having no evidence for efficacy, bloodletting, either with leeches or by making an incision with a “lancet,” became part of standard medical practice for more than 2500 years! Monks, priests and barbers got into the act along with physicians. In 1799 George Washington had more than half his blood drained in ten hours, certainly hastening his demise.
Many British doctors preferred leeches, especially in areas around the mouth, ears and eyes where lancing was a tricky procedure. They even learned how to encourage a leech to bite by stimulating its appetite with sugar or alcohol. But the creatures were in short supply, and had to be imported by the millions from France, Germany, Poland and Australia where they were often caught in nets using liver as bait. Sometimes poor children earned a little extra money by wading into infested waters to emerge, like the horses, with leeches attached to their legs. A gentle tug or a pass with a flame then relaxed the bloodsucker’s grip before much damage ensued. Good thing, because leeches can be pretty nasty once they latch on. Remember Humphrey Bogart flailing about in African Queen while trying to rid himself of the little vampires?
The lack of leeches caused some physicians to explore recycling techniques. Usually a single leech becomes satiated after filling up on about 15 milliliters of blood and then falls off. But then if it is plunked into salt water, it will disgorge the blood and is soon ready for another round. A German physician even developed a technique to encourage continued sucking by making an incision in the leech’s abdomen allowing for the ingested blood to drain out as fast as it came in. It seems the leech wasn’t much bothered by this affront to its belly and would go on sucking for hours. Amazingly, leeches were sometimes used internally. To treat swollen tonsils, a leech with a silk thread passed through its body would be lowered down the throat and withdrawn when it had finished its meal. Sometimes the creatures were even introduced into the vagina to treat various “female complaints.” The literature is vague about how this was done but one account suggests that the technique required a clever nurse.
While bloodletting as a general treatment for ailments has been drained out of the modern medicine chest, there is still work for leeches. That’s because their saliva is a complex chemical mix of pain killers and anticoagulants. Hirudin, for example, is the protein that keeps the blood flowing steadily after the initial bite is made, and is so effective that the blood will not coagulate for quite some time even after the leech falls off. Indeed, these bloodsucking aquatic worms have received approval from the U.S. Food and Drug Agency as a “medical device.”
Surgeons have been known to use leeches after reattaching ears, eyelids or fingers that have been severed, as well as after skin grafts. This has to do with the fact that arteries are easy to reconnect but veins are not. Eventually new capillaries do form to reconnect veins, but in the meantime the finger or ear fills with blood which then clots and causes problems with circulation. A leech will drain the excess blood at just the right rate and can prevent blood clot formation by injecting hirudin. This is such a potent anticoagulant that it holds hope for dissolving blood clots after a heart attack or stroke. Unfortunately hirudin is too difficult to extract from leeches but can potentially be produced through genetic engineering techniques.
Where do physicians get leeches today? No need for horses. They can order them directly from the French firm Ricarimpex. One would think that after helping to save a finger or an ear the useful little critters would be rewarded. But their destiny is death in a bucket of bleach. Not any better than ending up in a glue factory.
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Joe Schwarcz, Ph.D., is the Director of McGill University’s Office for Science and Society and teaches a variety of courses in McGill’s Chemistry Department and in the Faculty of Medicine with emphasis on health issues, including aspects of “Alternative Medicine”. He is well known for his informative and entertaining public lectures on topics ranging from the chemistry of love to the science of aging. Using stage magic to make scientific points is one of his specialties.
October 24th, 2012 by admin in Health Tips, Quackery Exposed
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Edzard Ernst, M.D., Ph.D.
Cancer patients are understandably desperate to try every treatment that promises a cure. They often turn to the Internet where they find thousands of “alternative” cancer cures being sold often for exorbitant cost. One of them is Ukrain.
Ukrain is based on two natural substances: alkaloids from the Greater Celandine and Thiotepa. It was developed by Dr Wassil Nowicky who allegedly cured his brother’s testicular cancer with his invention. Despite its high cost of about £50 per injection, Ukrain has become popular in the UK and elsewhere.
Ukrain has its name from the fact that the brothers Nowicky originate from the Ukraine, where also much of the research on this drug was conducted. When I say much, I should stress that I use this word in relative terms. In the realm of “alternative” cancer cures, we often find no clinical studies at all. For Ukrain, however, the situation is refreshingly different; there are a number of trials, and the question is, what do they really tell us?
In 2005, we decided to review all the clinical studies which had tested the efficacy of Ukrain. Somewhat to our surprise, we found 7 randomised clinical trials. Even more surprising, we thought, was the fact that all of them reported baffling cure rates. So, were we excited to have identified a cure for even the most incurable cancers? The short answer to this question is NO.
All of the trials were methodologically weak; but, as this is not uncommon in the area of alternative medicine, it did not irritate us all that much. Far more remarkable was the fact that these studies seemed to be odd in several other ways.
Their results seemed too good to be true; all but one trial came from the Ukraine where research governance might have been less than adequate. The authors of the studies seemed to overlap and often included Nowicky himself. They were published in only two different journals of little impact. The only non-Ukrainian trial came from Germany and was not much better: its lead author happened to be the editor of the journal where it was published; more importantly, the paper lacked crucial methodological details, which rendered the findings difficult to interpret, and the trial had a tiny sample size.
Collectively, these circumstances were enough for us to be very cautious. Consequently, we stated that “numerous caveats prevent a positive conclusion”.
Despite our caution, this article became much cited, and cancer centres around the world began to wonder whether they should take Ukrain more seriously; many integrative cancer clinics even started using the drug in their clinical routine. Dr Nowicky, who meanwhile had established his base in Vienna from where he marketed his drug, must have been delighted.
Soon, numerous websites sprang up praising Ukrain: “It is the first medicament in the world that accumulates in the cores of cancer cells very quickly after administration and kills only cancer cells while leaving healthy cells undamaged. Its inventor and patent holder Dr Wassil Nowicky was nominated for the Nobel Prize for this medicament in 2005…” .
Somehow, I doubt this thing with the Nobel Prize. What I do not question for a minute, however, is this press release by the Austrian police: since January, the Viennese police have been investigating Dr Nowicky. During a “major raid” on 4 September 2012, he and his accomplices were arrested under the suspicion of commercial fraud. Nowicky was accused of illegally producing and selling the unlicensed drug Ukrain. The financial damage was estimated to be in the region of 5 million Euros.
I fear, however, that the damage done on desperate cancer patients across the world might be much greater. Generally speaking, “alternative” cancer cures are not just a menace, they are a contradiction in terms: there is no such a thing and there will never be one. If tomorrow this or that alternative remedy shows some promise as a cancer cure, it will be investigated by mainstream oncology with some urgency; and if the findings turn out to be positive, the eventual result would be a new cancer treatment. To assume that oncologists might ignore a promising treatment simply because it originates from the realm of alternative medicine is idiotic and supposes that oncologists are mean bastards who do not care about their patients – and this, of course, is an accusation which one might rather direct towards the irresponsible purveyors of “alternative” cancer cures.
***
Dr. Ernst is a PM&R specialist and the author of 48 books and more than 1000 articles in the peer-reviewed medical literature. His most recent book, Trick or Treatment? Alternative Medicine on Trial is available from amazon. He blogs regularly at EdzardErnst.com and contributes occasionally to this blog.
January 6th, 2012 by Steve Novella, M.D. in Opinion, True Stories
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Dr. Ian Gawler, a veterinarian, suffered from osteogenic sarcoma (a form of bone cancer) of the right leg when he was 24 in 1975. Treatment of the cancer required amputation of the right leg. After completing treatment he was found to have lumps in his groin. His oncologist at the time was confident this was local spread from the original cancer, which is highly aggressive. Gawler later developed lung and other lesions as well, and was given 6 months to live due to his metastatic disease.
Gawler decided to embark on an alternative treatment regimen, involving coffee enemas, a vegetarian diet, and meditation. Eventually he was completely cured of his terminal metastatic cancer. He has since become Australia’s most famous cancer survivor, promoting his alternative approach to cancer treatment, has published five books, and now runs the Gawler Foundation.
At least, that is the story he believes. There is one major problem with this medical tale, however – while the original cancer was confirmed by biopsy, the subsequent lesions were not. His oncologist at the time, Dr. John Doyle, assumed the new lesions were metastatic disease and never performed a biopsy. It was highly probable Read more »
*This blog post was originally published at Science-Based Medicine*
